Clinical trials: Ventilator-induced Diaphragm Dysfunction
Ventilator-Induced Diaphragm Dysfunction
Study of TransAeris® System for Enhanced Recovery After Surgery in France
This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of…
- Trial name
- ERAS (NCT05404477)
- Testing
- TransAeris System
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Synapse Biomedical
Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence
Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
This multicenter randomized controlled trial aims to evaluate the efficacy of Shenfu Injection in preventing and treating ventilator dependence and ventilator-induced diaphragm dysfunction (VIDD) in critically ill adult patients…
- Conditions
- Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence, Ventilator Weaning
- Trial name
- NCT07880977
- Testing
- Shenfu Injection, 5% glucose injection
- Where
- China
- Volunteers
- 400 people
- Sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Mechanical Ventilation Complication, Ventilator-induced Diaphragm Dysfunction
How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children
The objective is to compare the impact of early mobilization and routine care on diaphragm thickness in critically ill children
- Trial name
- NCT04534296
- Testing
- early mobilization, routine care
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Children's Hospital of Fudan University
Ventilator-induced Diaphragm Dysfunction, VIDD
Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.
Up to 76% of ICU patients on mechanical ventilation develop significant respiratory muscle atrophy within the first 24 hours, contributing to prolonged ventilation, increased morbidity, and higher healthcare costs.
- Conditions
- Ventilator-induced Diaphragm Dysfunction, VIDD, Weaning Failure
- Trial name
- NCT07363902
- Testing
- Heecap
- Where
- 3 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Tesai Care SL
Ventilator Induced Diaphragmatic Dysfunction (VIDD)
PEPNS System Feasibility Study
The purpose of this feasibility study is to evaluate the safety and performance of the PEPNS System in patients that need to be mechanically ventilated for at least 48 hours and up to 7 days in the Intensive Care Unit (ICU).
- Trial name
- NCT03559933
- Testing
- PEPNS System
- Where
- 2 sites in Czechia, Ireland
- Volunteers
- 12 people
- Sponsor
- Stimdia Medical Inc.
Weaning From Mechanical Ventilation
Comparison of the Impact of Three Programs of Inspiratory Muscles.
Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning in intensive care have been performed, with…
- Trial name
- PREDRIC (NCT02855619)
- Testing
- Martin, Cader, EDRIC
- Where
- 2 sites in France
- Volunteers
- 92 people
- Sponsor
- University Hospital, Bordeaux
Ventilator-Induced Diaphragmatic Dysfunction
Therapeutically Alternatives In Ventilator-Induced Diaphragm Dysfunction Critically Ill Patients
The study is a prospective experimental study on adult patients admitted to the Critical Care Department in Qasr Al-Ainy. This study is conducted prospectively to assess the efficiency of trigger sensitivity adjustment on…
- Trial name
- NCT06515600
- Testing
- Practice flow trigger sensitivity adjustment on mechanical ventilation for 1 week twice daily in addition to their plan of treatment.
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- South Valley University
Ventilator Induced Diaphragm Dysfunction
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
A single-arm, prospective, multicenter cohort study to assess the 30-day continued safety and effectiveness of the AeroPace System in patients on mechanical ventilation (MV) at least 96 hours and who have not weaned.
- Trial name
- AERO-PAS (NCT07477054)
- Testing
- Lungpacer Diaphragm Pacing Therapy
- Volunteers
- 120 people
- Sponsor
- Lungpacer Medical Inc.
Ventilator-Induced Diaphragm Dysfunction
Pilot Study of TransAeris® System in Surgical Patients at Risk of Prolonged Mechanical Ventilation
This study will be conducted as a pilot trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of prolonged…
- Trial name
- TRANSITION (NCT04309123)
- Testing
- TransAeris System
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Synapse Biomedical
Muscle Atrophy or Weakness, Ventilator-associated Lung Injury
Serial Daily Diaphragm Ultrasounds in Ventilated Patients
When a person is put on a breathing machine the investigators think that the breathing muscles can get weaker. The investigators are not sure how quickly this happens but in some people this leads to problems when they try to…
- Trial name
- NCT02174029
- Testing
- Ventilation- mandatory, Ventilation- voluntary mode only, Voluntary with preceding mandatory
- Where
- Canada
- Volunteers
- 61 people
- Sponsor
- Steve Reynolds
Ventilator Induced Diaphragm Dysfunction
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
A randomized clinical trial to investigate the use of the temporary Diaphragm Pacing Therapy System (DPTS) to rehabilitate the diaphragm in mechanically ventilated patients who have failed at least two weaning attempts.
- Trial name
- RESCUE2 (NCT03096639)
- Testing
- Diaphragmatic Pacing Therapy DPTS
- Where
- 21 sites in France, Germany
- Volunteers
- 110 people
- Sponsor
- Lungpacer Medical Inc.
Restrictive Lung Diseases
Effects of Inspiratory Muscle Training and Positive Expiratory Pressure on Mechanically Ventilated Restrictive Lung Disease Patients
Restrictive lung diseases (RLD) represent a significant cause of morbidity, often necessitating intensive interventions such as mechanical ventilation due to diminished lung compliance (LC) and reduced total lung capacity (TLC).
- Trial name
- NCT07867730
- Testing
- Inspiratory muscle training, Conventional Chest Physical Therapy
- Where
- 3 sites in Pakistan
- Volunteers
- 30 people
- Sponsor
- Foundation University Islamabad
Mechanical Ventilation Complication
Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy
The objective of the study is to determine how controlled mode ventilation and support mode ventilation impact ventilator-free days and diaphragmatic atrophy.
- Trial name
- NCT03901924
- Testing
- Volume Support Mode Mechanical Ventilation, Assist Control Mode Mechanical Ventilation
- Where
- 2 sites in United States
- Volunteers
- 468 people
- Sponsor
- University of Chicago
Ventilator Induced Diaphragm Dysfunction
A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation
This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18…
- Trial name
- RESCUE 3 (NCT03783884)
- Testing
- Lungpacer Diaphragm Pacing Therapy
- Where
- 33 sites in United States, France and 1 more
- Volunteers
- 223 people
- Sponsor
- Lungpacer Medical Inc.
Chronic Obstructive Pulmonary Disease (COPD), Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Nutritional Risk and Diaphragmatic Thickness in Mechanically Ventilated COPD Patients
Malnutrition and muscle wasting are frequent complications in patients with chronic obstructive pulmonary disease (COPD) experiencing acute exacerbations.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Malnutrition, Respiratory Failure
- Trial name
- NCT07788170
- Volunteers
- 120 people
- Sponsor
- Assiut University
Ventilator Induced Diaphragm Dysfunction, Respiratory Muscle Weakness
Standardization of IMT Dosage (UTIT) in Mechanical Ventilation.
Respiratory muscle weakness prolongs mechanical ventilation (MV) and delays weaning. Currently, there is no standardized dosage for Inspiratory Muscle Training (IMT) in the ICU.
- Conditions
- Ventilator Induced Diaphragm Dysfunction, Respiratory Muscle Weakness, Mechanical Ventilation Weaning
- Trial name
- UTIT-IMT (NCT07761468)
- Testing
- Inspiratory Muscle Training (IMT)
- Where
- Mexico
- Volunteers
- 60 people
- Sponsor
- Hospital H+ Queretaro
Ventilation Therapy; Complications, Diaphragm Disease
Real-time Effort Driven VENTilator Management
This study is a Phase II controlled clinical trial that will obtain comprehensive, serial assessments of respiratory muscle strength and architecture to understand the evolution of ventilator-induced respiratory muscle weakness…
- Conditions
- Ventilation Therapy; Complications, Diaphragm Disease, Pediatric Respiratory Diseases
- Trial name
- REDvent (NCT03266016)
- Testing
- Computerized Ventilator Protocol, Esophageal Manometry, Respiratory Inductance Plethysmography (RIP)
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- Children's Hospital Los Angeles
Acute Respiratory Failure, Mechanically Ventilated Patients
Concurrent Trigger Sensitivity Adjustment And Diaphragmatic Facilitation On Weaning From Mechanical Ventilation
As Acute respiratory failure (ARF) is a challenging serious condition especially when it necessitates intubation to deliver mechanical ventilation which is a fundamental strategy for supporting the respiratory function when the…
- Trial name
- NCT05387720
- Testing
- Manual diaphragmatic facilitation (PNF) technique, Trigger sensitivity adjustment on mechanical ventilation, concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) technique
- Where
- Egypt
- Volunteers
- 75 people
- Sponsor
- Cairo University
Weaning Failure
Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle Strength and Accelerate Weaning in Medical Patients With Difficulty on Weaning?
Introduction: It has been described that invasive mechanical ventilation leads to diaphragm weakness. The inspiratory muscle weakness is related with a difficult and prolonged weaning as well as longer duration of mechanical…
- Trial name
- NCT04347317
- Testing
- Low Intensity IMT, High Intensity IMT
- Where
- 2 sites in Spain
- Volunteers
- 40 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Ventilator Induced Diaphragm Dysfunction
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE1)
An early feasibility study to investigate the safety and feasibility of the Lungpacer Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the diaphragm of patients who have been intubated and…
- Trial name
- RESCUE1 (NCT03107949)
- Testing
- Lungpacer DPTS (Diaphragm Pacing Therapy System)
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Lungpacer Medical Inc.